As advised in the FDA Guidance for Industry Oversight of Clinical Investigations — “A Risk-Based Approach to Monitoring ”, there is a growing consensus that risk-based approaches to monitoring focusing on the most critical data elements are more likely to ensure subject protection and overall study quality and will permit sponsors to monitor the conduct of clinical investigations more effectively. The EMA has also issued a similar reflection paper.

“Key Risk Indicators (KRIs) are obviously important, but the guidance also points out that you can use a more comprehensive statistical approach to interrogate the data, and this is exactly what our sister company CluePoints is doing. In fact, if you look at the FDA guidance, it explicitly states that you can target on-site monitoring by identifying higher risk clinical sites with findings that may or may not be related to critical data. So, that means that even non-critical data may be indicative of data problems, and, therefore, a statistical approach that looks at the totality of the data is crucial in addition to KRIs.” Marc Buyse, Scientific Officer, IDDI .